Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
STANDARD published on 1.8.2018
Why Redline?
A PDF redline is a quick and easy way to compare all of the changes between the current, active standard and the previous version.
With a redline you'll immediately see:
Save Time and Trouble!
With a Redline you no longer have to spend time trying to determine what has changed in the new standard! Redlines save you time and ensure you see what the changes are to the standard.
Price
When you select the "Active + Redline" option you get both documents! Best of all, the cost of an Active + Redline is only slightly more than buying the Active Standard by itself.
Designation standards: ASTM F2063-18
Publication date standards: 1.8.2018
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM
This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.
Keywords:
cardiac devices, metals, NiTi, TiNi, nitinol, nickel-titanium alloys, titanium-nickel alloys, orthopaedic medical devices, vascular devices, shape memory alloys, stents, superelastic alloys, surgical implants,, ICS Number Code 11.040.30 (Surgical instruments and materials)